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Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers

Protocol summary

Study aim
Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers
Design
parallel study
Settings and conduct
48 healthy subjects are enrolled. The study is a single-blind. In this study, under supervision of study investigators, a single dose of Injectable Extended-Release Naltrexone (380 mg), test or reference is administered intramuscularly to healthy subjects. For the measurement of pharmacokinetic parameters, 5 ml blood samples are taken before (0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration.
Participants/Inclusion and exclusion criteria
inclusion criteria: healthy volunteers exclusion criteria: Significant history or presence of gastrointestinal, kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. Any clinically significant illness during the 4 weeks prior to day of this study.
Intervention groups
The administration of two products is carried out by a randomized and parallel study design. Subjects are randomly divided into two equal groups and assigned to one of the two groups of drug administration. Exopio®, as a test drug, is administered in one group and Vivitrol®, as a reference drug, is administered in another group.
Main outcome variables
drug concentration in blood plasma

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130603013572N4
Registration date: 2020-08-10, 1399/05/20
Registration timing: prospective

Last update: 2020-08-10, 1399/05/20
Update count: 0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Mohammadreza Rouini
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 9056
Email address
rouini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers
Public title
Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
healthy male and female volunteers Age: between 18 and 55 years old BMI: between 18.5 and 30 kg/m2
Exclusion criteria:
History of hypersensitivity to the study drug or related products. Significant history or presence of gastrointestinal, kidney disease or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. Significant history of asthma, chronic bronchitis or other broncho spastic condition.Significant history or presence of glaucoma, cardiovascular or hematological disease. Any clinically significant illness during the 4 weeks prior to day of this study. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. Participation in a clinical trial with an investigation drug within 30 days preceding day 1 of this study. Use of enzyme- modifying drugs within 30 days prior to day 1 of this study. Use of any systemic medication (including OTC preparations) within 14 days prior to day 1 of this study. HIV and Hepatitis B and anti HCV antibody positive subjects. Smoking History of difficulty in donating blood Donation of blood within 90 days before first dosing. History of vaccination within one month before first dosing.
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization administrating of test or reference product for each subject is determined according to the randomization schedule. The randomization schedule is prepared according to volunteer's allocated number. Each subject is identified by a number from 1 to 48 according to their entrance to volunteers' list in screening day. Randomly, Subjects with odd numbers receive the test drug and the subjects with even number receive the reference drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
Volunteers are blind in this study. The volunteers, according to the predetermined random table that is available to the researcher, are in one of the groups receiving the test or reference drug. Volunteers are aware that they are receiving the test drug (Iranian) and the reference drug (approved drug), but they do not know in which study period they will receive the test and reference drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor in research affairs- Tehran university of medical sciences
Street address
Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.TUMS.VCR.REC.1399.341

Health conditions studied

1

Description of health condition studied
Bioequivalence Study of Injectable Extended-Release Naltrexone (380 mg) of Nano Daru pharma Co. (Exopio®) and Vivitrol® (as a reference) in Iranian Healthy volunteers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
determination of drug concentration in blood plasma
Timepoint
(0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration
Method of measurement
High performance liquid chromatography

Secondary outcomes

1

Description
time to peak plasma concentration
Timepoint
(0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration
Method of measurement
observational

2

Description
maximum plasma concentration
Timepoint
(0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration
Method of measurement
observational

3

Description
Area under the plasma concentration–time curves
Timepoint
(0 min) and at 1, 2, 4, 8, 12, 24, 32, 38, 48 and 58 hours and 3, 5, 7, 10, 14, 18, 24, 30 days after administration
Method of measurement
linear trapezoidal method

Intervention groups

1

Description
Intervention group: Single dose administration of Injectable Extended-Release Naltrexone (Exopio®) (380 mg) manufactured by Nano Daru pharma Co. in 24 healthy volunteers
Category
Other

2

Description
Control group: Single dose administration of Injectable Extended-Release Naltrexone (Vivitrol®) (380 mg) manufactured by Alkermes pharma Co. in 24 healthy volunteers
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran university of medical sciences
Full name of responsible person
Mohammadreza Rouini
Street address
16th Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 9056
Fax
+98 21 6695 9056
Email
rouini@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nano Daru pharmaceutical Co.
Full name of responsible person
Dr. Navid Godarzi
Street address
Northern Tak Ave., Attar St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994754953
Phone
+98 21 8864 9081
Email
goodarzi@nanodaru.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nano Daru pharmaceutical Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rouini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics and Biopharmaceutics
Street address
16 Azar street, Tehran university of medical sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 9056
Email
rouini@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rouini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics and Biopharmaceutics
Street address
16 Azar street, Tehran university of medical sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 9056
Email
rouini@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rouini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics and Biopharmaceutics
Street address
16 Azar street, Tehran university of medical sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 9056
Email
rouini@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only protocol and methods of study are shareable
When the data will become available and for how long
Starting access 6 months after publication of data
To whom data/document is available
Pharmaceutical and medical sciences researchers
Under which criteria data/document could be used
Using is not authorized
From where data/document is obtainable
contact with E-mail of the main researcher
What processes are involved for a request to access data/document
Personal and academic details and the aim of data request.
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